Background Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but its efficacy remains controversial. Current experimental research postulates different efficiency among PRP formulations.Recent reviews showed that most clinical studies in tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy of pure-PRP in the management of epicondylitis.

Methods and design Randomized double blind controlled trial, a total of 80 patients will be randomly allocated into one of two groups: PRP or control. Interventions: PRP group, ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate week for a total of two interventions. Control Group: US-guided needling with lidocaine each alternate week for a total of two interventions. Main outcome measure: Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome measure score, before and six months after intervention.The primary end-point is 25% reduction in DASH. The investigators will compare the percentage of patients, in each group, that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.

Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up. Changes in sonographic features and neovascularity at 3, 6 and 12 months.

ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions

Drug: US-guided tenotomy with PRP

Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected.

Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure

Other Name: pure-PRP (without leukocytes)

Active Comparator: US-guided tenotomy with lidocaine

ultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions

Drug: US-guided tenotomy with lidocaine

Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure

Other Name: local anesthetic

Eligibility

Ages Eligible for Study:

35 Years to 75 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria

Tendinopathy present in either lateral or medial elbow

Pain by palpation at the lateral or medial epicondyle of the elbow

Baseline elbow pain >3/10 during resisted wrist extension

History of at least two periods of elbow pain lasting more than 10 days

Received local steroid injection within 3 months of randomization received nonsteroidal antiinflammatory, opioids or oral corticosteroids within 15 days before inclusion in the study

Severe heart diseasePatients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.

Patients with active cancer or cancer diagnosed in the last five years.

Analytical Diagnosis Hepatitis B, C or HIV infection.

Pregnant or lactating.

People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01945528